prikaz prve stranice dokumenta Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group
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Scientific paper - Original scientific paper
Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group
Haematologica, 95 (2010), 9; 1489-1495. https://doi.org/10.3324/haematol.2009.018580
Labar, Boris; Suciu, Stefan; Willemze, Roel; Muus, Petra; Marie, Jean-Pierre; Fillet, Georges; Berneman, Zwi; Jakšić, Branimir; Fereman, Walter; Bron, Dominique; Sinnige, Harm; Mistrik, Martin; Vreugdenhil, Gerard; de Bock, Robrecht; Nemet, Damir; Gilotay, Caroline; Amadori, Sergio; De Witte, Theo More authors...

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Labar, B., Suciu, S., Willemze, R., Muus, P., Marie, J. P., Fillet, G. ... De Witte, T. (2010). Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group. Haematologica, 95. (9), 1489-1495. doi: 10.3324/haematol.2009.018580

Labar, Boris, et al. "Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group." Haematologica, vol. 95, no. 9, 2010, pp. 1489-1495. https://doi.org/10.3324/haematol.2009.018580

Labar, Boris, Stefan Suciu, Roel Willemze, Petra Muus, Jean Pierre Marie, Georges Fillet, Zwi Berneman, et al. "Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group." Haematologica 95, no. 9 (2010): 1489-1495. https://doi.org/10.3324/haematol.2009.018580

Labar, B., et al. (2010) 'Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group', Haematologica, 95(9), pp. 1489-1495. doi: 10.3324/haematol.2009.018580

Labar B, Suciu S, Willemze R, Muus P, Marie JP, Fillet G, and sur.. Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group. Haematologica [Internet]. 2010 September [cited 2024 November 30];95(9):1489-1495. doi: 10.3324/haematol.2009.018580

B. Labar, et al., "Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group", Haematologica, vol. 95, no. 9, pp. 1489-1495, September 2010. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:448295. [Accessed: 30 November 2024]

Metadata
Title (english)Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group
AuthorBoris Labar
AuthorStefan Suciu
AuthorRoel Willemze
AuthorPetra Muus
AuthorJean-Pierre Marie
AuthorGeorges Fillet
AuthorZwi Berneman
AuthorBranimir Jakšić
AuthorWalter Fereman
AuthorDominique Bron
AuthorHarm Sinnige
AuthorMartin Mistrik
AuthorGerard Vreugdenhil
AuthorRobrecht de Bock
AuthorDamir Nemet
AuthorCaroline Gilotay
AuthorSergio Amadori
AuthorTheo De Witte
Author's institutionUniversity of Zagreb
School of Medicine
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Abstract (english)
Background Corticosteroids are the standard component for the treatment of ALL and LL patients. Our aim was to assess whether dexamethasone (DXM) result in a better outcome than Prednisolone (PDN). Design and Metdhods Adult ALL and LL patients were randomized to receive in induction on days 1-8, 15-22, either DXM 8 mg/m(2) or PDN 60 mg/m(2). Those who reached complete remission (CR), two courses of consolidation (HAM and MA) were administered. Subsequently patient younger than 50 years, with a donor, had to receive AlloSCT, whereas the others, either autoSCT or high dose maintenance chemotherapy with prophylactic CNS irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival (EFS). Analysis were done by intention to treat. RESULTS: Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either DXM (163 patients) or PDN (162 patients). After induction and first consolidation course, 131 (80,4%) patients in DXM group and 124(76,5%) in PDN group achieved CR. No significant difference was observed between the 2 treatment groups regarding EFS: P=0.82, hazard ratio 0.97, 95% confidence interval 0.75-1.25, the 6-year EFS rates (+/-SE) were 25.9%(3.6%) vs. 28.7% (3.5%). Disease-Free survival (DFS) from CR was similar in DXM and PDN group: hazard ratio1.03, 95% confindence interval 0.76-1.40. The 6-year DFS rate was 32.3% (DXM) vs. 37,5% (PDN) group, the 6-year cummulative incidence of relapse was 32.3 (DXM) vs. 37.5% (PDN) group, the 6-year cumulative incidence of relapse was 49.8% vs. 53.5% (Gray test: P=0.30) and of death was 18% vs. 9% (Gray test: P=0.07). Conclusions In the ALL-4 trial in adult patients, DXM did not show any advantage compared to PDN. This study is registered with Clinical Trials gov. number NCT00002700.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review
Publication versionPublished version
Journal titleHaematologica
Numberingvol. 95, no. 9, pp. 1489-1495
p-ISSN0390-6078
DOIhttps://doi.org/10.3324/haematol.2009.018580
URN:NBNurn:nbn:hr:105:448295
Publication2010-09
Document URLhttps://doi.org/10.3324/haematol.2009.018580
Type of resourceText
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2024-03-28 11:36:13